FDA Inspection 571368 — Fenwal Inc
The FDA completed an inspection of Fenwal Inc on March 20, 2009 in Lake Zurich, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lake Zurich, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |